DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 11/17/2025 have been received and entered into the case. Claims 19-21 have been canceled. Claims 1-18 and 22-23 are pending, Claims 1-18 have been withdrawn, and Claims 22-23 have been considered on the merits. All arguments have been fully considered.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in view of applicant’s amendments.
Rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections under 35 U.S.C. 102(a)(1) are withdrawn in view of applicant’s amendments.
Rejections of Claims 22-23 under 35 U.S.C. 103 as being unpatentable over Akhmerov et al (Circulation Research. 2020;126:1443-1455.) in view of Mozos et al (Dis Markers. 2017:2017:1-14.) are withdrawn in view of applicant’s amendments.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Dound et al (WO 2021/191864 A1; 9/30/2021.) in view of Shioi et al (Nutrients. 2020;12:583.).
The instant claims recite a method of treating COVID-19 disease in a patient in need thereof, the method comprising administering to the patient a composition comprising vitamin K to treat COVID-19 disease, wherein said vitamin K is administered in an amount that reduces dp-ucMGP levels.
Dound teaches a food / nutraceutical supplement comprising vitamin K used for the preventive management of severe acute respiratory syndrome coronavirus and COVID-19 (p.5 para 3), wherein vitamin K has a potential role in prevention of COVID-19 (p.8 para 2), and the food / nutraceutical supplement is administered to a subject suffering from said disease using any amount, any form of pharmaceutical dosage form via any route of administration effective for treating the disease (p.10 para 5).
Dound does not teach vitamin K in an amount that reduces dp-ucMGP levels (claim 22) as well as the claimed amount (claim 23).
However, Dound does teach a food / nutraceutical supplement comprises vitamin K is used for the preventive management of severe acute respiratory syndrome coronavirus and COVID-19, wherein vitamin K has a potential role in prevention of COVID-19, and the food / nutraceutical supplement is administered to a subject suffering from said disease using any amount effective for treating the disease. Before the effective filing date of the claimed invention, it was well-known in the art that vitamin K reduces dp-ucMGP levels, as evidenced by Shioi. Shioi teaches vitamin K supplementation dose-dependently decreased dp-ucMGP levels in the groups with 180, 360, 720, and 1080 µg (p.6 para 3).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer the claimed amount of vitamin K to reduce dp-ucMGP levels, since Shioi discloses that the claimed amount of vitamin K is known to reduce dp-ucMGP levels. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to administer the claimed amount of vitamin K to reduce dp-ucMGP levels with a reasonable expectation of success.
Response to Arguments
Applicant argues that Knight does not anticipate the current claims. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Applicant argues that none of the cited references make the current claims obvious. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759